Ventilated prosthesis system

ABSTRACT

A prosthesis system including a ventilated shell, and a substantially compliant, ventilated spacer element that defines a first surface having a frictional feature. The spacer element is arranged to secure to an internal surface of the shell. The prosthesis system also includes a connector that is secured to a distal end of the shell, and a retainer supported by the connector so as to extend into a cavity formed by the shell.

CROSS REFERENCE TO RELATED APPLICATIONS

This application is a divisional of U.S. application Ser. No. 11/723,595filed on Mar. 21, 2007, which claims the benefit of priority of U.S.provisional application 60/785,344, filed on Mar. 24, 2006.

FIELD OF THE INVENTION

This invention relates to a ventilated prosthesis system for a residuallimb.

BACKGROUND OF RELATED ART

Existing prosthetic sockets on residual limbs tend to be bulky andcumbersome to wear. They may also be difficult to don and make theresidual limb uncomfortable when worn due to a lack of ventilation.Moreover, most prosthetic sockets are permanently formed, thereby notaccounting for swelling of a residual limb. These sockets also requiretime to be constructed, and there are very few socket options for newamputees prior to receiving a socket after surgery.

It is desirable to provide a simplified and compact prosthesis systemthat overcomes the drawbacks over known prosthesis systems. Further, itis desirable to provide a prosthesis system that can be worn temporarilyand adjusted accordingly.

SUMMARY

Embodiments of the present invention are directed to a prosthesis systemthat serves to ventilate a residual limb, provide adjustable settings,and is easy to don. Moreover, these embodiments provide a streamlinedprosthesis system that is lightweight and has a slim profile. Theprosthesis system may be worn without custom settings, and may furtherserve as a transition or temporary prosthesis socket system prior to apermanently fitted socket system of a more traditional type.

In accordance with one embodiment, the prosthesis system includes aventilated shell forming anterior, lateral and medial portions, and asubstantially compliant, ventilated spacer element that defines a firstsurface having a frictional feature. The spacer element serves as abuffer between the shell and the residual limb. The prosthesis systemalso includes a connector that is secured to a distal end of the shell.The connector has a proximal side defining a recess. A retainer isprovided for insertion within the proximal side recess of the connectorso as to extend into a cavity formed by the shell.

In another embodiment, the shell includes anterior and posterior shells.The anterior shell is secured to the connector, whereas the posteriorshell is connected to the anterior shell by straps extendingtherebetween. The spacer element forms a tubular liner having a closeddistal end and an open proximal end.

In yet another embodiment, the shell forms a definitive, custom fittedsocket. Similarly, the spacer element forms a tubular liner having aclosed distal end and an open proximal end.

Numerous variations of the components used in the prosthesis system aredescribed more fully in the following description.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects, and advantages of the presentinvention will become better understood with regard to the followingdescription, appended claims, and accompanying drawings.

FIG. 1 is an exploded perspective view showing an embodiment of aventilated prosthesis system according to the invention.

FIG. 2 is a perspective view showing the embodiment of FIG. 1.

FIG. 3 is a side elevational view showing the embodiment of FIG. 1.

FIG. 4 is a perspective view showing another embodiment of a ventilatedprosthesis system.

FIG. 5 is a perspective view showing yet another embodiment of aventilated prosthesis system.

FIG. 6 is a perspective view showing an embodiment of a shell of FIG. 4.

FIG. 7 is a sectional view showing an embodiment of the shell of FIG. 4.

FIG. 8 is a sectional view showing a variation of the shell of FIG. 7.

FIG. 9 is a sectional plan view showing an embodiment of the spacerelement construction.

FIG. 10 is a sectional elevational view showing a cross-sectionalvariation of the spacer element construction of FIG. 9.

FIG. 11 is a perspective view showing an embodiment of a spacer elementin tubular form.

DETAILED DESCRIPTION OF VARIOUS EMBODIMENTS

A. Overview

A better understanding of different embodiments of the invention may behad from the following description read in conjunction with theaccompanying drawings in which like reference characters refer to likeelements.

While the disclosure is susceptible to various modifications andalternative constructions, certain illustrative embodiments are shown inthe drawings and will be described below in detail. It should beunderstood, however, that there is no intention to limit the disclosureto the specific embodiments disclosed, but on the contrary, theintention is to cover all modifications, alternative constructions,combinations, and equivalents falling within the spirit and scope of thedisclosure and defined by the appended claims.

It will be understood that, unless a term is expressly defined in thispatent to possess a described meaning, there is no intent to limit themeaning of such term, either expressly or indirectly, beyond its plainor ordinary meaning.

Any element in a claim that does not explicitly state “means for”performing a specified function, or “step for” performing a specificfunction, is not to be interpreted as a “means” or “step” clause asspecified in 35 U.S.C. § 112, paragraph 6.

Some of the components described herein share similarities to componentsin pending U.S. application Ser. No. 11/312,337, incorporated herein byreference and belonging to the assignee of this disclosure.

B. Environment and Context of Embodiments

Numerous embodiments of the invention are provided for assisting a legamputee with a ventilated prosthesis system. Embodiments of theinvention may be configured for both above the knee and below the kneeamputees. The components of the embodiments may be adapted for otherlimbs and anatomy.

Embodiments of the invention may be dimensioned to accommodate differenttypes, shapes and sizes of amputated legs. In addition, embodiments areadjustable to compensate for varying degrees of swelling and variableconditions of a residual limb.

For explanatory purposes, the embodiments described herein are dividedinto sections which are denoted by general anatomical terms for thehuman body. These terms include dividing the prosthesis system intoanterior and posterior sections by an anterior-posterior plane. Theanterior-posterior plane generally corresponds to the coronal or frontalplane of a human leg. Each of the anterior and posterior sections isfurther divided about the center of the leg by a proximal-distal planeand a lateral-medial plane.

The anatomical terms described herein are not intended to detract fromthe normal understanding of such terms as readily understood by one ofordinary skill in the art of orthotics and prosthetics.

C. Various Embodiments of the Prosthesis System

i. Overview of Prosthesis System Embodiments

One embodiment of the prosthesis system according to the invention isshown in FIGS. 1-3. The prosthesis system 10 includes an anterior shell12 having a cavity 82 that is adapted to receive a residual limb. Aspacer element 14 is provided for location along an upper surface 78 ofthe shell 12, and is arranged to be intermediate of the residual limband the shell 12. A connector 18 is attached to a distal end 42 of theshell 12. The connector 18 is arranged to receive a retainer 16 whichextends into the cavity 82 of the shell 12. Suitable straps 24 areconnected to the shell 12, particularly on medial and lateral sidesthereof which are provided for securing the shell 12 to the residuallimb.

The ventilated prosthesis system 10 may be connected to a suitableprosthetic knee 58, pylon 60, and foot 62, as schematically depicted inFIGS. 4 and 5. It will be understood that one skilled in the art mayconnect other suitable components to the prosthesis system according todifferent applications.

While the foregoing embodiment has been described and shown, details asto different embodiments and variations of the components used thereinwill be described in more detail in the following discussion. Moreover,modifications of this embodiment and variations thereof will also beincluded in the following discussion. For example, the shellconfiguration and variations thereof may be used in applications that donot necessitate the connector, as in orthotic devices for securing limbsand other anatomy.

ii. Shells

FIGS. 1-3 illustrate one embodiment of the shell that may be used in theprosthesis system according to the invention. In this embodiment, theshell 12 is configured to cover portions of the anterior, lateral andmedial sides of the residual limb. The shell of this embodiment may not,however, be configured to cover much, if any, of the posterior portionof the residual limb. This embodiment enables a user to tightly securethe shell onto the residual limb with the straps 24. This embodimentalso enables the user to adjust the straps 24 according to differentdegrees of swelling the residual limb might undergo.

According to other embodiments, the shell may comprise a single part ormultiple parts that surround portions of the both the anterior andposterior sides of the residual limb, or may define a socket having asimilar construction that surrounds the residual limb in knownprosthetic sockets, as described in U.S. Pat. Nos. 6,416,703 and6,589,289, incorporated herein by reference and belonging to theassignee of this disclosure.

For example, FIG. 5 shows an embodiment of the shell 12 as forming ananterior shell and the shell 64 forming a posterior shell. These twoopposing shells 12, 64 are connected by the straps 66. While theanterior shell 12 is preferably connected to the connector 18, asdiscussed below, the posterior shell 64 may be constrained by the straps66 which connect to the anterior shell 12. The straps 66 may beshortened so as to reduce the cavity 82, and may further be elastic soas to draw the posterior shell 64 towards the anterior shell 12 whenworn by a user with suitable adjustments.

In a variation of the embodiment of FIG. 5, the posterior shell 64includes a lower segment 69 (shown in hidden lines) that extends to theconnector 18. The lower segment 69 is shown as defining a cut-awaysection generally corresponding to a posterior portion of the connector18 so as to permit rotation of the posterior shell 64 relative to theconnector 18.

The lower segment 69 includes lateral and medial sides that connect to apin or hinge device 71 secured to the connector 18. The pin or hingedevice 71 allows the posterior shell 64 to be pivotally connected to theconnector 18, and facilitates the donning of the anterior shell 12 andthe posterior shell 68 on a residual limb by maintaining the connector,anterior and posterior shells together.

It will be understood that since the lower segment 69 of the posteriorshell 64 is attached to the connector 18, a variation of thisarrangement may include only the posterior shell 64 as being connectedto the connector. It follows that the shell 12 itself is not directlysecured to the connector and is only connected to the connector via thestraps 66 linking it to the posterior shell 64.

Another embodiment is shown in FIG. 6 which includes a shell thateffectively forms a definitive socket 70 which is of the type describedin the aforementioned patents. This socket 70 includes a ventilationfeature 72 that is generally uniformly formed and spaced in at least theproximal portion of the socket 70. The socket 70 is preferably formed toa general or specific the shape of a residual limb.

Returning to the basic embodiment of FIGS. 1-3, the shell 12 includes aventilation feature 30. The ventilation feature 30 is defined by aplurality of slots 31 defined in a pattern. The slots 31 may includevarious shapes and sizes. In other variations, the ventilation feature30 may be defined by any shape or size of opening that will provide atransfer of vapor and moisture from the residual limb through the shell12.

Examples of other variations of the ventilation feature are shown inFIGS. 7 and 8. In each of these variations, the shell 12 may be providedwith sections having only the ventilation feature, or the shell 12 inits entirety may have the ventilation feature. One variation is shown inFIG. 7, and by way of FIGS. 4-6, wherein the shell 70 has circularopenings 73 that extend through the thickness of the shell body 74thereof. The variation of FIG. 7 also exemplifies how the shell 12 mayinclude a peripheral lip 75 that defines a groove 77 between the shellbody 74 and the lip 75. The groove 77 is sized and configured toaccommodate and retain a spacer element. The peripheral lip 75 may beprovided in continuous or segments along the periphery of the shell 12.

Alternatively, the variation of FIG. 8 shows a grid or meshconfiguration 76 that is finer in size than the openings 72 of FIGS.4-6. The mesh configuration 76 may be continuous across the shell 12, orlocated at specific locations bordered with reinforcement sections 79that provide additional structure and strength to the mesh configuration76.

Referring again to the embodiment of FIGS. 1-3, the shell 12 includesappropriate openings 48, 49 appropriate for receiving detachablemounting brackets or buckles 28 for connecting the straps 24 to theshell 12. In addition, the shell 12 includes appropriate openings 32 forsecuring the connector 18 thereto.

The construction of the shell may be similar to the construction of theshells in U.S. patent application Ser. No. 11/312,337. For example, theshell 12 may include a compliant feature 90 located about the entiretyor at least a portion about the periphery of the shell. The compliantfeature provides a pressure-relieving flexible perimeter edge portion tothe shell which accommodates sensitive skin and muscle areas of a wearersurrounding the shell.

The compliant feature 90 is preferably constructed of a material that ismore flexible or softer than the material comprising the shell. Thecompliant feature 90 is arranged to extend beyond the outer perimeter ofa main body of the shell, and is preferably a flexible resilientmaterial that is secured to the shell by “overmolding,” bonding,mechanical interlocking or any other suitable arrangement. An example ofa method for providing the compliant feature is described in U.S. Pat.No. 5,445,602, incorporated herein by reference and belonging to theassignee of this disclosure.

In another example of the compliant feature, the shell may beconstructed by a combination of rigid frame members with at least oneflexible subshell having a compliant feature surrounding the peripherythereof. Exemplary materials that may be used for constructing the frameinclude metals such as aluminum, titanium, and steel, thermoset resincomposite systems including glass or carbon fibers, and thermoplasticsthat have been rendered rigid by way of material composition andgeometry of the frame members.

The sub-shell is substantially more flexible than the substantiallyrigid frame. While it is preferred that the rigid frame does not yieldto the residual limb when worn, the sub-shell sufficiently is flexibleso as to bend and conform to the residual limb. The rigid frame andflexible subshells may be configured in accordance with any of the shellembodiments described herein.

The compliant feature is distinguished from a main body portion in thatit preferably has a softer texture. More specifically, the compliantfeature has a hardness that is lower than the hardness of the main body.In one variation, the main body and the compliant feature are injectionmolded thermoplastics that are integrally molded together. An exemplarycombination of materials comprises thermoplastic polyurethane elastomerssold under the name ELASTOLLAN by BASF group.

In any of the embodiments described herein, the shell may be customsized and contoured to accommodate the leg of a particular wearer of thebrace. Also, the shell may be preformed to curve to the contour of aresidual limb, or curved as a result of the tension of the strapsadjusted between lateral and medial sides of the shell. While theembodiment described herein assumes that the shell may be sufficientlyflexible to accommodate a residual limb, the shell can also beconfigured to be substantially rigid. Whether the shell is configuredfor temporary and universal usage irrespective of a particular residuallimb, or permanent usage for a particular limb, the stiffness of theshell may he arranged or modified accordingly.

The shell may be constructed of a variety of materials such as TRIAX(abs/nylon blend), polypropylene, polyethylene, nylon, carbon or glassfiber prepeg with thermosetting or thermoplastic resins, and rigid foamfrom EVA, platezote or polyurethane. In another variation, the proximaland distal shells may be constructed similarly to the orthotic sleevedescribed in U.S. Pat. No. 6,592,539, incorporated herein by referenceand belonging to the assignee of this disclosure.

iii. Spacer Element

As shown in the embodiment of FIGS. 1-3, the spacer element 14 iscontoured in a similar configuration to the shells 12. This spacerelement 14 is arranged with a ventilation feature 20 so as to bebreathable by permitting a free flow of air therethrough. The spacerelement 14 preferably also includes a friction feature 22 on at leastone side thereof.

This embodiment of the spacer element 14 is secured or merely worn orarranged adjacent to the rear surface of the shell 12. The spacerelement may be connected to the shell via removable means, such as witha hook and loop fastener system, or may alternatively be secured to theshell via stitching, adhesives, or other similar fastener features.Alternatively, the spacer element may be retained by the shell via thegrooves described in connection with the shell variation of FIG. 7. Thisembodiment of the spacer element is intended to provide sufficientfrictional force to maintain the shell against the residual limb atleast partly due to the straps 24 and the frictional feature.

In the embodiment of FIGS. 1-3, the ventilation feature 20 comprises apattern of openings defined across the spacer element 14 between theborders 21 of the spacer element 14. Alternatively, the ventilationfeature 20 may comprise a breathable fabric, and may be combined with apattern of perforations to further enhance the breathability of thespacers. Further yet, the spacer element may be constructed from amaterial that provides cushioning and compresses, at least in part, whenthe prosthesis system is worn.

The friction feature 22 is preferably provided on least a rear surface46 the spacer element 14. This friction feature 22 has a high frictionalcoefficient against the skin or clothing. Moreover, the friction feature22 does not occlude the ventilation feature 20 of the spacer element 14,and permits a transfer of air through the spacer.

Alternatively, the friction feature 22 may be provided on both front andrear surfaces of the spacer. This particular variation enables thespacer element to frictionally engage the shell, and may be providedwith additional securing means for engagement with the shell. In yetanother alternative, the spacer element may be constructed of sectionsof elasticized fabric and coated on at least the rear surface withsilicone of the type described in U.S. Pat. No. 6,592,539.

As shown in FIGS. 1-3, the spacer element 14 may have a mesh or coreportion that permits the passage of air therethrough, and yet iscompressible to provide adequate cushioning and securing to a residuallimb when the prosthesis system is worn. In addition, the border 21 ofthe spacer element preferably includes a reinforced edging provided toprotect the core portion, and enhance the durability of the spacer.

Preferred substrate materials that may be used to form a substrate forthe spacer element include foams, neoprene, and textiles. While numerousmaterials may be used as the spacer material, it is desirable that thesematerials have a three-dimensional knit structure covered by a mesh thatprovides sufficient breathability, insulation, compression, durability,and recovery. An exemplary spacer, material is a three-dimensionalfabric produced by Gehring Textiles under product numbers SHR 701, SHR714 or SHR 754F.

The rear surface of the spacer element may include the friction featurecomprising a continuous, discrete layer of cured silicone composition.The silicone composition is preferably sufficiently thick and soft to becomfortable to the user, and provides a seal against the residual limb.The friction feature may have apertures which correspond to apertures ofthe mesh surface of the three-dimensional fabric when such a fabric isused to form the substrate of the spacer. In an alternate variation, thesilicone coating may comprise a plurality of dots, lines or otherdiscrete portions of suitable geometry which are deposited to thesurface of the substrate forming the spacer.

The silicone composition may be mixed with scenting, anti-inflammatory,anti-bacterial, and coloring agents. Moreover, the silicone compositionmay include skin friendly agents such as aloe vera or Vaseline. A morecomplete description of additives to the silicone may be found in U.S.Pat. No. 6,485,776, incorporated herein by reference and belonging tothe assignee of this disclosure.

The silicone composition preferably has a Shore hardness of 25-70; aminimum tensile strength of 230 lbs/inch; a 100% modulus of 8 psi; a500% modulus of 61 psi; a minimum tear strength of 49 lbs/inch; amaximum strength of 500 lbs/inch and an elongation of about 1000%.

It will be noted that the friction feature may comprise a variety ofmaterials in addition to silicone. Such materials include those havingfrictional features which may be skin-friendly, and can be laminated,bonded or coated onto a substrate to form the spacer.

The friction feature may be disposed in a uniform thickness in bothcircumferential and longitudinal directions, or may have a varyingthickness to accommodate varying shapes of a leg, protrusions, contours,etc. The friction feature can also be configured to have a specificrelief from localized pressure that may result from installation spacerelement on a residual limb.

An example of a possible configuration of the spacer element is providedin FIGS. 9 and 10. FIG. 9 shows a surface of the spacer element 100having a friction feature 102 with a plurality of apertures 104. FIG. 10shows the spacer element having a spacer material comprising athree-dimensional fabric having a plurality of filaments 110 bounded byfabric surfaces 106, 108. The frictional feature 102 corresponds tonon-apertured surfaces of the fabric surface 106, thereby defining holes104.

In another variation (not shown), the spacer element does not include afriction feature. This spacer element would merely provide a compressivebuffer between the shell and the residual limb. In yet anothervariation, the spacer element may comprise a textile having superiorfrictional properties, and as a result, merely the compression of thetextile is sufficient to frictionally secure the spacer element againstthe residual limb.

In yet another variation, the spacer element may comprise a siliconemesh comprising a textile that is impregnated with silicone. Thissilicone mesh defines a pattern of apertures that permit the transportof air therethrough. In yet another variation, the spacer element isformed from a silicone sheet having a pattern of apertures, andsufficient thickness to serve as a buffer between the residual limb andthe shell.

The spacer element 14 is not limited to the configuration of FIGS. 1-3.On the contrary, the spacer element 14 may form a tubular liner thatsurrounds the entirety of the leg, as in a silicone liner described inU.S. Pat. No. 6,136,039, incorporated by reference and belonging to theassignee of this disclosure. Such a liner may be tubular having openends or a closed distal end for use with the anterior and posteriorshells 12, 64 shown in the embodiment of FIG. 5, or the socket 70 in theembodiment of FIG. 6.

FIG. 11 depicts an embodiment of a tubular liner 91 having an open endand a closed end. The general geometry of this liner is described inU.S. Pat. No. 6,136,039 and understood by those skilled in the art as asuspension liner for residual limbs. More specifically, the tubularspacer element 91 includes a spacer material 92 that is apertured andincludes a friction feature on the inner surface (not shown), similar tothe construction shown in FIGS. 9 and 10. The tubular spacer element 91includes at least one elongate rib 94 extending from a distal baseportion 96 adapted for mating with the connector. The rib 94 serves inpart to provide structural support to the spacer material 92, and maycover any seam. In a variation, a plurality of spaced elongate ribs maybe provided about the spacer material 92.

iv. Connector

In the embodiment shown in FIGS. 1-3, the connector 18 is arranged witha recess 36 for receiving the retainer 16. The connector 38 includes apin 38 for connection to a corresponding adaptor locating on aprosthetic knee, prosthetic foot, pylon or other suitable prostheticdevice.

The connector 18 has a means for connecting to the shell 12. Accordingto the embodiment shown in FIGS. 1-3, the connector 18 includes aplurality of pins or buttons 40 which extend about the outer peripherythereof. These buttons 40 are adapted to extend through the openings 32of the shell 12. While there are various ways of securing the buttons 40to the shell 12, some examples include forming the openings 32 so thatthe buttons 40 interlock with the shell 12, or alternatively the buttons40 are resiliently urged through the openings and secured therewith.This requires the shell 12 or the buttons 40 to be sufficientlyresilient to permit the buttons 38 to compliantly pass through theopenings 32.

Other suitable means may be used to connect the shell to the connector.Such means may include bonding the shell to the connector such that thedistal portion of the shell forms a ring which encircles the connector.Alternatively, the connector may be integrally formed with the shell.

While in the embodiment of FIGS. 1-3 the connector 18 has a recess 36,the connector may be provided without the recess 36. Accordingly,suitable connecting pin(s) may be used, such as those known to skilledartisans in the field of prosthetics, to interlock with a correspondingadaptor on the retainer 16. Such known methods for connecting prostheticdevices include pyramid and socket adaptors, and clamps.

The connector 18 may be constructed from any suitable materialunderstood by those skilled in the art to be used in typical adaptersfor prosthetic devices. Such materials include rigid plastics, steel,aluminum and titanium alloys, carbon fiber or other fiber composites,and combinations thereof.

v. Retainer

In the embodiment shown in FIGS. 1-3, the retainer 16 is configured forplacement within the recess 36 of the connector 18. The retainer 16 hasa generally concave surface 34 which is disposed within the cavity 82 ofthe shell 12. The retainer 16 is shaped and dimensioned to follow thecontour of the distal end 42 of the shell 12.

The concave surface 34 is preferably contoured to accommodate the distalend of a residual limb. The concave surface 34 can also be configured inother shapes or may be formed of a custom shape for the residual limb.

The retainer 16 is supportive of the weight of the user of theventilated prosthesis system 10. This variation of the retainer 16 ispreferably constructed of a silicone elastomer that is of sufficientthickness to sustain its shape upon supporting the residual limb. Aswith the silicone-based frictional feature 22 of the spacer element 14,the retainer may include additives such as aloe vera and petroleum jellyin order to provide skin treatment qualities.

In other variations, the retainer 16 may be constructed from materialssuch as plastics or composite fiber systems. Alternatively, the retainer16 may comprise foam, rubber or other suitable materials.

As indicated above, the retainer 16 may be configured so that it isattached to the connector 18. The retainer 16 may be modified to includesuitable connecting means to secure it against the connector.

vi. Straps

In the embodiment of FIGS. 1-3, straps 24 are used to secure theventilated prosthesis system to the residual limb. The straps 24 may beelastic, substantially elastic or inelastic. Tightening means may beused to secure the length of the strap, and maintain the length of thestrap when the prosthesis system 10 is worn.

Regarding this embodiment, each of the straps 24 includes a cushionfeature 26, such as foam or a textile pad that is secured thereon forenhanced rotational prevention and additional comfort. The straps eachhave an adjustment feature (not shown), such as a hook and loop fastenersystem, to enable adjustment of the length of such straps. Moreover, thecushion feature may include a frictional feature (not shown), such as apattern of deposited silicone, rubber, or a mildly abrasive material. Inaddition, the cushion feature may be breathable, and have a constructionsimilar to the spacers.

In one variation, the straps may be releasably secured to the kneebrace. For example, the straps may include a snap fastener element thatcorresponds to a snap fastener element supported by shell of theprosthesis system. In another variation, other suitable releasablefasteners may be used to permit installation and removal of the strapsfrom the shell.

Turning to the embodiment of FIG. 5 wherein the shell 12 includesanterior and posterior portions 12, 64, the straps 66 are mounted onopposed sides of the shells 12, 64 thereby forming a clamshell with theshells 12, 64. These straps 66 may be substantially elastic in order todraw the posterior shell 64 towards the anterior shell 12, oralternatively be substantially inelastic in order to prevent gradualextension of the straps as the prosthesis system is worn.

In variations, the straps 24 may be secured to the shell 12 in any ofthe ways described in U.S. patent application Ser. No. 11/312,330. Suchstraps may also have suitable tightening means that permit incrementaladjustment, such as any of those described in Ser. No. 11/312,330.

vii. Other Embodiments

The various embodiments and the variations thereof described above inaccordance with the prosthesis system of the present invention presentsan amputee a comfortable and ventilated alternative to known prosthesissystems. The inventive prosthesis system is lightweight and has astreamlined profile that is simple to use for wearers of the system ofvarious age groups. Patient comfort is also enhanced and donning anddoffing of the system is eased with the novel features of the presentprosthesis system. Versatility is also obtained since a singleprosthesis system according to the invention may be sized and configuredto a accommodate a variety of residual limbs with necessitating customsizing of the system's components.

Of course, it is to be understood that not necessarily all such objectsor advantages may be achieved in accordance with any particularembodiment of the invention. Thus, for example, those skilled in the artwill recognize that the invention may be embodied or carried out in amanner that achieves or optimizes one advantage or group of advantagesas taught herein without necessarily achieving other objects oradvantages as may be taught or suggested herein.

The skilled artisan will recognize the interchangeability of variouscomponents from different embodiments described herein. In addition tothe variations described herein, other known equivalents for eachfeature can be mixed and matched by one of ordinary skill in this art toconstruct a prosthesis system in accordance with principles of thepresent invention. Moreover, the embodiments and components thereofdescribed herein are not limited for use in prosthetic systems, but maybe adapted to orthopedic systems for securing, supporting or comfortinglimbs or other anatomy.

Although this invention has been disclosed in the context of certainpreferred embodiments and examples, it therefore will be understood bythose skilled in the art that the present invention extends beyond thespecifically disclosed embodiments to other alternative embodimentsand/or uses of the invention and obvious modifications and equivalentsthereof. Thus, it is intended that the scope of the present inventionherein disclosed should not be limited by the particular disclosedembodiments described above, but should be determined only by a fairreading of the claims that follow.

1. An orthotic or prosthetic system comprising: a ventilated socketincluding an anterior shell and a posterior shell having inner surfaces;a substantially compliant, ventilated spacer element adjacent to thesocket and defining a first surface having a frictional feature, thespacer element having a section corresponding to the anterior shell; aconnector secured to a distal end of the anterior shell; and at leastone strap connecting the anterior shell to the posterior shell.
 2. Theorthotic or prosthetic system according to claim 1, wherein theposterior shell is pivotally attached to the connector and having apivotal relationship relative to the anterior shell.
 3. The orthotic orprosthetic system according to claim 1, wherein the shell includes a lipdefining a groove between the lip and the inner surface, the groovearranged and sized to retain the spacer element relative to the shell.4. The orthotic or prosthetic system according to claim 1, wherein thespacer element generally is a tubular liner defining an open end and aclosed-end, an inner surface of the tubular liner having the frictionfeature disposed thereon.
 5. The orthotic or prosthetic system accordingto claim 1, wherein the spacer element comprises a spacer materialhaving opposed first and second surfaces, the frictional feature being asilicone composition generally extending across at least one of thefirst and second surfaces in a manner so as to air circulation throughthe spacer material.
 6. An orthotic or prosthetic system comprising:ventilated and flexible anterior and posterior shells each having aninner surface, the anterior and posterior shells forming a cavity; asubstantially compliant, ventilated spacer element arranged forplacement adjacent to the shell inner surfaces and including abreathable spacer material defining opposed first and second surfaces, africtional feature being provided along at least one of the first andsecond surfaces, the frictional feature including a composition havingfrictional properties and extending across the at least one of the firstand second surfaces in a manner so as to permit air circulation throughthe spacer material and the shells; and at least one strap connecting toopposed sides of the shells; wherein the friction feature resistsmovement of objects located directly adjacent thereof.
 7. The orthoticor prosthetic system according to claim 6, wherein the spacer elementgenerally is a tubular liner defining an open end and a closed-end, aninner surface of the tubular liner having the friction feature disposedthereon.
 8. The orthotic or prosthetic system according to claim 6,wherein the spacer element has a spacer material including athree-dimensional fabric.
 9. The orthotic or prosthetic system accordingto claim 6, wherein the spacer element is releasably secured to theshell.
 10. The orthotic or prosthetic system according to claim 6,wherein the frictional feature is a continuous layer of a siliconecomposition.
 11. The orthotic or prosthetic system according to claim 6,wherein the first surface of the spacer element includes a plurality ofapertures, the frictional coating having apertures corresponding to thefirst surface apertures.
 12. The orthotic or prosthetic system accordingto claim 6, wherein the shell includes a plurality of through-extendingopenings.
 13. The orthotic or prosthetic system according to claim 6,farther comprising a stability strap connecting to lateral and medialsides of the shell, and generally spanning a posterior side of theshell.
 14. The orthotic or prosthetic system according to claim 6,wherein the stability strap is attached to a buckle assembly releasablyconnected to one of the lateral and medial sides of the shell.
 15. Theorthotic or prosthetic system according to claim 6, wherein the retaineris generally cylindrical and has a concaved recess formed at a proximalend.
 16. The orthotic or prosthetic system according to claim 6, whereinthe tubular liner includes at least one elongate rib extending along anouter surface of the tubular liner.
 17. The orthotic or prostheticsystem according to claim 6, wherein the spacer element comprises abreathable substrate having opposed first and second surfaces, thefrictional feature being a silicone composition generally extendingacross at least one of the first and second surfaces in a manner so asto permit ventilation through the breathable fabric.
 18. An orthotic orprosthetic system comprising: a ventilated socket including an anteriorshell and a posterior shell having inner surfaces; a substantiallycompliant, ventilated spacer element adjacent to the socket and defininga first surface having a frictional feature, the spacer element having asection corresponding to the anterior shell; a connector secured to adistal end of the anterior shell; at least one strap connecting theanterior shell to the posterior shell; and a retainer provided withinthe proximal side recess of the connector; the retainer having generallycylindrical and having a concaved recess formed at a proximal endthereof.
 19. The orthotic or prosthetic system according to claim 18,wherein the posterior shell is pivotally attached to the connector andhaving a pivotal relationship relative to the anterior shell.